Knotless suture fastener installation system

ABSTRACT

A knotless suture fastener installation system for securing medical devices such as cardiac implants. The knotless suture fasteners may be spring-biased so as to grip onto sutures passed therethrough. The system includes a fastener deployment tool with a proximal handle and a distal shaft to which a fastener cartridge attaches. A plurality of disposable cartridges are sequentially attached to the end of the deployment tool and used to secure the medical implant one fastener at a time. The deployment tool may also cut the sutures being fastened.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/438,404, filed Feb. 21, 2017, now U.S. Pat. No. 10,426,458, which isa continuation of U.S. patent application Ser. No. 14/329,797, filedJul. 11, 2014, now U.S. Pat. No. 9,592,048, which claims the benefit ofU.S. Patent Application No. 61/845,359, filed Jul. 11, 2013, all ofwhich are incorporated by reference herein in their entireties.

FIELD

The present invention relates generally to a system for installingknotless suture fasteners onto sutures used, for example, to securemedical implants without requiring suture knots.

BACKGROUND

Heart valve disease is a widespread condition in which one or more ofthe valves of the heart fails to function properly. Various surgicaltechniques may be used to repair a diseased or damaged valve, includingsecuring a cardiac implant to the diseased annulus. Cardiac implantsinclude a prosthetic heart valves and annuloplasty rings. In a valvereplacement operation, the damaged leaflets are excised and the annulussculpted to receive a replacement valve. About one-half of patientsreceive a mechanical heart valve, which are composed of rigid, syntheticmaterials, and the remaining patients received bioprosthetic heart valvereplacements, which utilize biologically derived tissues for flexiblefluid occluding leaflets. Another less drastic method for treatingdefective valves is through repair or reconstruction, which is typicallyused on minimally calcified valves. One repair technique that has beenshown to be effective in treating incompetence is annuloplasty, in whichthe deformed valve annulus is reshaped by attaching a prostheticannuloplasty repair segment or ring to the valve annulus.

In a typical cardiac implant procedure, the aorta is incised and, in avalve replacement operation, the defective valve is removed leaving thedesired placement site that may include a fibrous tissue layer orannular tissue. Known cardiac implant techniques include individuallypre-installing sutures through the fibrous tissue or desired placementsite within the valve annulus to form an array of sutures. Free ends ofthe sutures are draped out of the thoracic cavity and are spaced apart,sometimes being distributed around a suture organizer The free ends ofthe sutures are then individually threaded through a suture-permeablesewing edge of the annuloplasty ring or prosthetic heart valve. Once allsutures have been run through the sewing edge (typically 12 to 18sutures), all the sutures are pulled up taught and the prosthesis isslid or “parachuted” down until it sits against the target annulus. Thecardiac implant is then secured in place by traditional knot tying ofthe anchoring sutures on the proximal side of the sewing edge. There areoften 7-10 knots on each suture advanced by pushing the knot one at atime to the desired location by using a knot pusher device. Thisprocedure is obviously time-consuming.

During open-heart procedures, the patient is on heart-lung bypass whichreduces the patient's oxygen level and creates non-physiologic bloodflow dynamics. The longer a patient is on heart-lung bypass, the greaterthe risk for complications including permanent health damage. Existingtechniques for suturing cardiac implants extend the duration of bypassand increase the health risks due to heart-lung bypass. Furthermore, thesecuring force created by suturing varies significantly because thepre-tensioning of the suture just prior to knot tying is difficult toconsistently maintain, even for an experienced medical professional.

There exists a need for devices and methods that reduce the timerequired to secure a medical implant in place. Additionally, thereexists a need to make it easier to secure a cardiac implant, inparticular, in place. Currently, a clinician must work in the limitedspace near the heart to tie knots in sutures. This is a cumbersomeprocess even for a clinician of great dexterity and patience.

SUMMARY

The present application discloses an installation system for securing anannuloplasty ring or a prosthetic heart valve to a heart valve annulususing knotless suture fasteners. The knotless suture fasteners aredesirably spring-biased so as to self-actuate and grip onto annulusanchoring sutures passed therethrough. The system includes a fastenerdeployment tool with a proximal handle and a distal shaft to which afastener cartridge attaches. A plurality of disposable cartridges aresequentially attached to the end of the deployment tool and used tosecure the medical implant one fastener at a time. The deployment toolmay also cut the sutures being fastened.

A preferred embodiment of the present application includes a system forsecuring a suture without knots, comprising a reusable deployment toolhaving a distal shaft terminating in a distal tip, the tool including anejector movable within the distal shaft, and a plurality ofpre-assembled, disposable fastener cartridge and suture snaresubassemblies. Each subassembly has a cartridge having a lumen thatreceives a single suture fastener within a distal end thereof, aproximal end of the cartridge lumen being sized to engage the distal tipof the deployment tool shaft. The suture fastener includes clampingstructure that can be flexed to an open condition through which a suturecan pass and is biased toward a closed position which clamps onto asuture passed therethrough. The cartridge has at least one stop thatmaintains the suture fastener in its open condition. The subassemblyfurther includes a suture snare having an elongated flexible snareportion size to pass radially inward through aligned ports in theengaged cartridge and tool shaft and distally through the suturefastener in its open condition. The snare portion is adapted to captureand pull a suture proximally through the suture fastener and out of thealigned ports in the cartridge and tool shaft. When the cartridge isengaged with the deployment tool, movement of the ejector contacts andconverts the suture fastener from its open condition to its closedcondition to clamp onto a suture passed therethrough.

Another system for securing a suture without knots disclosed hereinincludes a deployment tool with a distal shaft terminating in a distaltip having locking structure thereon, the tool including an ejectormovable within the tool shaft, and the tool shaft having a side portadjacent the distal tip. The system includes a suture fastener havingclamping structure that can be flexed to an open condition through whicha suture can pass and which is biased toward a closed position whichclamps onto a suture passed therethrough. A fastener cartridge as alumen that receives the suture fastener at a distal end and has at leastone stop that maintains the suture fastener in its open condition. Aproximal end of the cartridge having mating structure for engaging thelocking structure of the distal tip of the deployment tool shaft, andthe cartridge also has an access port that aligns with the side port ofthe tool shaft when the two are engaged. Finally, a suture snareincludes an elongated flexible snare portion size to pass through theaccess port of the cartridge, through the side port of the tool shaft,and distally through the suture fastener in its open condition. Movementof the ejector contacts and converts the suture fastener from its opencondition to its closed condition to clamp onto a suture passedtherethrough.

In either of the systems described above, the deployment tool preferablyhas a proximal handle with a trigger, and the ejector is longitudinallymovable within the tool shaft upon actuation of the trigger. The ejectormay further include a sharp edge such that movement thereof also seversa suture extending through the suture fastener and out of the alignedports in the cartridge and tool shaft.

Preferably, the suture fastener comprises a disk-shaped main body, andthe clamping structure comprises at least one tab separated from themain body with slits and being spring-biased toward the closed conditionwhere the tab is aligned with the main body, and the cartridge includesat least one stop that maintains the suture fastener in its opencondition flexes the tab away from alignment with the main body.

Desirably, the suture snare comprises a proximal handle connected to theelongated flexible snare portion in the form of a flexible loop, and agrip/key having a peripheral groove for receiving and holding open theflexible loop, and wherein the grip/key is demountably attached to adistal end of the cartridge.

In a preferred embodiment, the cartridge is generally tubular and theproximal end includes an L-shaped slot terminating in a circular lockoutthat receives a locking pin extending outward from the deployment toolshaft, the cartridge engaging the distal tip of the deployment toolshaft by axially advancing and then rotating thereover to position thelocking pin in the circular lockout. The distal tip of the deploymenttool shaft may have an L-shaped slot with an axially-extending portionand a circumferential portion, and wherein the axially-extending portionaligns with a first of the aligned ports located on the cartridge toavoid binding on the snare portion when engaging the cartridge to thetool shaft, and the circumferential portion terminates in a second ofthe aligned ports located on the tool shaft, the first and secondaligned ports only being aligned when the cartridge and tool shaft arefully engaged.

In accordance with one aspect, a method for securing an implant withoutknots initially includes the step of pre-installing a plurality ofsutures at an anatomical location and passing the sutures through asuture-permeable portion of an implant. A fastener cartridge and suturesnare subassembly is attached to a distal tip of a shaft of a deploymenttool. The cartridge has a lumen that receives a single suture fastenerwithin a distal end thereof and at least one stop that maintainsclamping structure of the suture fastener in an open conditionspring-biased toward a closed condition. The suture snare includes anelongated flexible snare portion sized to pass radially inward throughaligned ports in the attached cartridge and tool shaft and distallythrough the suture fastener in its open condition. The method includessnaring one of the pre-installed sutures with the snare portion,advancing the cartridge along the suture to the implant with thedeployment tool until the suture fastener is adjacent to thesuture-permeable portion, actuating an ejector within the tool shaft tocontact and convert the suture fastener from its open condition to itsclosed condition in which the clamping structure clamps onto the suture,and severing the suture.

The aforementioned methods may further include one or more of the stepsof:

removing the cartridge from the distal tip of the deployment tool shaft;

attaching a second fastener cartridge and suture snare subassembly tothe distal tip of the deployment tool shaft;

snaring a second one of the pre-installed sutures with the snareportion;

advancing the second cartridge along the second suture to the implantwith the deployment tool until the second suture fastener is adjacent tothe suture-permeable portion;

actuating an ejector within the tool shaft to contact and convert thesecond suture fastener from its open condition to its closed conditionin which the clamping structure clamps onto the suture; and

severing the second suture.

The implant is desirably selected from the group consisting of anannuloplasty ring and a heart valve. The suture fasteners preferablyeach comprise a disk-shaped main body, and the clamping structurecomprises at least one tab separated from the main body with slits andbeing spring-biased toward the closed condition where the tab is alignedwith the main body, and the at least one stop that maintains the suturefastener in its open condition flexes the tab away from alignment withthe main body. Furthermore, the deployment tool may have a proximalhandle with a trigger for actuating the ejector, and the ejector furtherincludes a sharp edge such that movement thereof also severs the sutureextending through the suture fastener and out of the aligned ports inthe cartridge and tool shaft.

A further understanding of the nature and advantages of the presentinvention are set forth in the following description and claims,particularly when considered in conjunction with the accompanyingdrawings in which like parts bear like reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

The disclosed technology will now be explained and other advantages andfeatures will appear with reference to the accompanying schematicdrawings wherein:

FIG. 1 is a top view of an exemplary annuloplasty ring implanted at themitral annulus using knotted sutures;

FIG. 2 is a top view of an exemplary annuloplasty ring implanted at themitral annulus using exemplary suture fasteners in place of knots tosecure the sutures;

FIG. 3A is a perspective view of an exemplary suture fastener having twotabs that are separated from a generally disc-shaped body by a modifiedH-shaped slit;

FIG. 3B is another perspective view of the suture fastener of FIG. 3A,showing the fastener engaged with two sutures;

FIG. 3C is a perspective view of another suture fastener again havingtwo tabs and a suture retention recess on each;

FIG. 3D is a perspective view of another suture fastener with two tabsand serpentine sections on both sides of a central slit to help retainsutures therein;

FIG. 4A is a perspective view of another exemplary suture fastenerhaving four tabs that are formed in a generally disc-shaped body;

FIG. 4B is a sectional perspective view of the suture fastener of FIG.4A engaged with a suture;

FIG. 4C is a plan view and FIG. 4D a side view of the suture fastener ofFIG. 4A engaged with a suture;

FIGS. 5 and 6 are perspective views of exemplary curved suture fastenershaving C-shaped slits forming a biased tab;

FIGS. 7 and 8 are perspective views of two other suture fasteners havingtwo tabs that are separated from a curved body;

FIG. 9 is a perspective view of an exemplary system for installing thesuture fasteners disclosed in the present application, including areusable deployment tool and a disposable fastener cartridge and snaresubassembly;

FIG. 9A is an enlarged perspective view of the disposable fastenercartridge and snare subassembly adjacent the distal end of thedeployment tool;

FIG. 10 is a perspective view of an alternative disposable fastenercartridge and snare subassembly;

FIG. 11A is a longitudinal sectional view of the deployment tool of FIG.9;

FIGS. 11B-11E are sectional and perspective views of portions of thedeployment tool illustrating various moving parts therein;

FIG. 12A is a perspective view of the distal end of an exemplarydisposable fastener cartridge;

FIGS. 12B and 12C are sectional views of the fastener cartridge of FIG.12A showing a fastener at the distal end held open by internal features,and illustrating the path of a suture snare therethrough;

FIG. 12D is an isolated perspective view of an exemplary internal ribused within the fastener cartridge of FIG. 12A;

FIG. 13A is a top plan view of the disposable fastener cartridge justprior to engagement with a distal tip of the deployment tool, and FIG.13B is a perspective view of the fastener cartridge after engaging thedeployment tool, and showing placement of a suture snare therethrough;

FIGS. 14A-14D are longitudinal sectional views through the disposablefastener cartridge on the end of the deployment tool illustrating stepsin deploying the suture fastener;

FIG. 15A is a perspective cutaway view of an aortic annulus showing astep in attachment of a surgical prosthetic heart valve using knotlesssuture fasteners and a deployment tool of the present application;

FIG. 15B is a view as in FIG. 15A showing a final step in attachment ofthe prosthetic heart valve with the knotless suture fasteners anddeployment tool;

FIGS. 16A-16D illustrate several steps in loading an exemplarydisposable fastener cartridge to a distal tip of the deployment tool andthen preparing a suture snare for use;

FIGS. 17A-17F show sequential steps in operation of the deployment tooland fastener cartridge during installation of a suture fastener on theproximal side of an annuloplasty ring;

FIGS. 18A-18C show the steps necessary for disengagement of a usedfastener cartridge from the distal tip of the deployment tool;

FIG. 19 is a perspective cutaway view of the exemplary disposablefastener cartridge of FIGS. 16A-16D; and

FIG. 20 is an exploded perspective view of the fastener cartridge and asuture fastener that is held therein.

DETAILED DESCRIPTION

The present application provides improved systems for securing a cardiacimplant to a heart valve annulus using knotless suture fasteners.Proximal and distal refer to the opposite directions toward and away,respectively, a surgeon performing the implant. The term cardiac implantas used herein primarily refers to prosthetic heart valves andannuloplasty rings or segments. However, the suture fastening systemsdescribed herein can be used to attach other prostheses such as stents,grafts, stent-grafts, fluid delivery reservoirs, electro-stimulators, orthe like. Furthermore, the cardiac implants are desirably secured at atarget heart valve annulus, but the suture fastening systems may also beused to attach implants to other anatomical structures such as vessels,organs (e.g., intestine, heart, skin, liver, kidney, stomach) or otherlocations where sutures are typically used to attach the implant.Indeed, the present suture fastening systems can be used to securetissue structures together, such as for closure of vascular punctures orother wound closure.

Several exemplary embodiments of knotless suture fasteners are disclosedherein and shown in the attached figures. These embodiments should notbe construed as limiting in any way. Instead, the present disclosure isdirected toward all novel and nonobvious features and aspects of thesuture fastening systems described herein, alone and in variouscombinations and sub-combinations with one another, and regardless ofwhat type of suture fastener is used. The suture fasteners can secure asingle suture or to two or more sutures at the same time.

The disclosed suture fasteners all engage a suture by first threading afree end of the suture through an opening in the fastener. For example,the embodiment shown in FIGS. 3 and 4 require that an end of a suture bethreaded through an enclosed opening in the suture fastener. One or morebiased tabs are held open and then permitted to flex close to clamp ontothe suture. The tabs are separated from a main body of the fastener byslits, and the main body is generally disc-shaped, planar or non-planar.The various tabs and other such spring-biased structure are inclusivelytermed, “clamping structure.” Although a biased (spring-biased) type ofsuture fastener is preferred, certain aspects described herein may beuseful with closures that are plastically deformable. For example, thefasteners disclosed in U.S. Pat. No. 5,520,702 to Sauer include atubular body that is crimped so as to deform around and clamp onto asuture, and such deformable fastener may be used in the systemsdescribed herein with certain modifications such as providing adeforming hammer

Once a knotless suture fastener is positioned on a suture and released,the fastener can prevent the suture from sliding axially through thedevice in one or both longitudinal directions of the suture. In someembodiments, the device can be biased to allow the suture to slidethrough the device in one longitudinal direction, but prevent the suturefrom sliding in the opposite direction, forming a one-way suture lock,or ratchet mechanism. In other embodiments, the device can prevent thesuture from sliding in both longitudinal directions, forming a morerestrictive two-way suture lock.

By using the disclosed knotless suture fasteners rather than tying knotsin the sutures, the sutures can be secured in less time and with lessdifficulty (especially in hard-to-reach locations). In addition, someknotless suture fasteners can allow the amount of slack left in thesutures to be more precisely controlled, the devices can be less likelyto come loose than knots, and some embodiments of the devices can beeasily removed or adjusted after they are initially deployed.Furthermore, the knotless suture fasteners can be small, durable,biocompatible, and inexpensive.

FIG. 1 shows an exemplary prosthetic device in the form of anannuloplasty ring 2 secured to the annulus of a native mitral valve 4using sutures 6. Ends of the sutures 6 are secured together usingconventional knots 8. FIG. 2 shows the same annuloplasty ring 2 securedto the mitral annulus using exemplary knotless suture fasteners 10instead of knots. Twelve devices 10 are used in this example, thoughdifferent numbers of devices can be used in other implementations. Inthis example, each device 10 secures together two sutures 6 extendinggenerally in parallel and through the annuloplasty ring 2, in place of astandard knot. In other examples, a separate device 10 can be secured toeach suture 6 at the location where the suture passes through theannuloplasty ring 2. Either way, the devices 10 prevent the sutures 6from sliding through the devices toward the annuloplasty ring 2, keepingthe sutures taut and keeping the ring 2 secured against the mitral valvetissue 4. In some embodiments, such as the devices 10 shown in FIG. 2,the devices also allow the sutures 6 to be further tightened after aninitial deployment to reduce any excess slack in the sutures. Though theexemplary knotless suture fasteners 10 are shown in the example of FIG.2, any of the embodiments disclosed herein can be used for the same orsimilar purposes on other implementations.

While FIG. 2 shows an annuloplasty ring being secured by devices 10, thedevices 10, as well as the other embodiments of knotless suturefasteners disclosed herein, can be used to secure other prostheticdevices to tissue in the body. Other prosthetic devices include, forexample, prosthetic heart valves, stents, grafts, and various otherprosthetic implants conventionally secured to tissue using sutures.

FIGS. 3A and 3B show embodiments of a closed, non-biased suture fastener30. The suture fastener 30 comprises a generally flat disk-shaped bodyhaving an annular outer edge 32 and two tabs 34, 36 as clampingstructure that extend inwardly from the outer edge 32. Each tab 34, 36is shaped generally in a half-circle. The tabs 34, 36 are separated fromthe outer body at their sides by curved slots 38, 40 and are separatedfrom each other by a straight slit 42 generally bifurcating the suturefastener 30. The curved slots 38, 40 and middle slit 42 connect to eachother but do not intersect with an outer edge 32, thus forming a“closed” generally H-shaped opening extending from one face of thesuture fastener to the other. In the closed condition, the tabs 34, 36are aligned with the disk-shaped body. One or more sutures 43 can beinserted into the slit 42 from either the top or the bottom, deflectingboth tabs 34, 36 in the direction of insertion, as shown in FIG. 3B.Once the sutures 43 are inserted as shown in FIG. 3B, the suturefastener 30 is biased toward its relaxed, flat configuration, and allowsthe sutures to move axially upward with little resistance but preventsthe sutures from moving axially downward. In some embodiments, thegripping edges of the tabs 34, 36 can be sharp (see FIG. 3A), which canprovide better grip on the sutures, and in other embodiments thegripping edges of the tabs can be rounded (see FIG. 3B), which canreduce the likelihood of damaging and/or cutting the sutures. In someimplementations of the suture fastener 30 (not shown), the two tabs 34,36 can be elastically deformed in opposite directions with one tabbending upwardly out-of-plane and the other tab bending downwardlyout-of-plane. This can lock the sutures from sliding in either directionthrough the suture fastener 30. The two sutures 43 shown in FIG. 3B cancorrespond to free ends of the sutures 6 shown in FIG. 2, for example.

FIG. 3C shows a suture fastener 44 that is a variation of the suturefastener 30 wherein the gripping surfaces of the tabs 34, 36 comprisenotched or recess regions 45 that can help contain the sutures withinthe slit 42 and prevent them from sliding into the curved slits 38, 40.

FIG. 3D shows a still further variation of the suture fastener 46 havinga flat generally disk-shaped body having an annular outer edge 32′ andtwo tabs 34′, 36′ as clamping structure that extend inwardly therefrom.As in FIG. 3A, each tab 34′, 36′ is shaped generally in a half-circle.The tabs 34′, 36′ are separated from the outer body at their sides bycurved slots 38′, 40′ and are separated from each other by a slit 42′that has a straight midsection. Once again, the curved slots 38′, 40′and middle slit 42′ connect to each other but do not intersect with anouter edge of the body 32′, thus forming a “closed” generally H-shapedopening extending from one face of the suture fastener to the other. Ina closed condition, the tabs 34′, 36′ are aligned with the disk-shapedbody. One or more sutures can be inserted into the slit 42 from eitherthe top or the bottom, deflecting both tabs 34, 36 in the direction ofinsertion, as was shown in FIG. 3B. Once the sutures 43 are inserted inthe slit 42, the suture fastener 46 becomes biased and allows thesutures to move axially upward with little resistance but prevents thesutures from moving axially downward. As mentioned above, the grippingedges of the tabs 34, 36 may be sharp for better grip on the sutures, orrounded to reduce the likelihood of damaging and/or cutting the sutures.

To help retain sutures in the midsection of the slit 42′, the slitincludes serpentine sections 47 on either side. The tabs 34′, 36′ areidentical, or mirror images of each other, though one may be larger thanthe other. Small circular enlargements 48 on the terminal end of eachcurved slot 38′, 40′ facilitate bending of the tabs 34′, 36′ and act asstress relievers to reduce the chance of fracture at those points. Twosemi-circular cutouts 49 are provided on opposite sides of the outeredge 32′ perpendicular to the straight section of the slit 42′. Thecutouts 48 provide orientation features for the suture fastener 46 thatcooperate with features on a tool (not shown) which can hold and deploymultiple suture fasteners in series.

FIGS. 4A-4D show an embodiment of a closed, biased suture fastener 50.The suture fastener 50 comprises an annular outer body 52, and twoengagement tabs 54, 56 and two side tabs 58, 60 extending inwardly fromthe outer body 52. The tabs 54, 56 and/or the tabs 58, 60 can alsoextend upwardly out-of-plane from the outer body 52. The engagement tabs54, 56 can comprise concave engagement surfaces 62 to keep the suture 64centered between them. The side tabs 58, 60 can prevent the suture 64from sliding laterally out from between the engagement tabs 54, 56. Theengagement tabs 54, 56 are biased to allow the suture 64 to slideupwardly through the suture fastener 50 with little resistance butprevent the suture from sliding downwardly through the suture fastener.

Some suture fasteners can be relatively thin, disk-shaped members buthave a generally curved rather than a planar shape. The embodimentsshown in FIGS. 5-8 are examples of suture fasteners having a curvedshape. In these embodiments, the suture fastener can have an upper majorsurface that is generally convex and a lower major surface that isgenerally concave. The upper and lower major surfaces are substantiallyparallel to each other, with the suture fasteners having a substantiallyconstant thickness between the two major surfaces. In some embodiments,the upper and lower major surfaces are curved in one direction andnon-curved in a perpendicular direction (like a sidewall of a cylinder),such that the surfaces have central axis of curvature. In someembodiments, both major surfaces have a common central axis ofcurvature. In other embodiments, the major surfaces are curved in othermanners, such as having concentric spherical major surfaces that share acommon center of curvature. By providing suture fasteners with a curvedstructure, the fasteners can be biased to provide greater resistance tosutures moving toward the concave direction while more readily allowingsutures to move toward the convex direction.

In some embodiments, such curved suture fasteners are formed from asidewall of a tube. The outer radius of the tube can define thecurvature of the convex major surface of the suture fastener while theinner radius of the tube can define the curvature of the concave majorsurface of the device. The uniform thickness of a curved suture fasteneris equal to the wall thickness of the tube that the device is cut from.In other embodiments, the suture fasteners are formed from a sidewall ofa non-cylindrical tube, or from a wall of other three-dimensionalobjects having a curved wall, such as a hollow sphere, spheroid,ellipsoid, etc., or from other three-dimensional objects having acurvature.

FIG. 5 shows an exemplary embodiment of a curved suture fastener 100.The suture fastener 100 comprises an annular outer body 102 and an innerbody, or tab, 104 that is separated from the outer body by a “C” shapedslit 106. The convex, upper major surface of the suture fastener 100 isshown in FIG. 5. The tab 104 has an elliptical shape and extends from aconnection to the outer body in the direction of the curvature of thesuture fastener. One or more sutures can be inserted through the slit106 from the concave, lower side of the suture fastener 100, causing thetab 104 to deflect upwardly. With sutures inserted through the slit 106,the biased tab 104 pinches the sutures and prevents them from slidingback through the slit toward the concave direction. Thus, the suturefastener 100 is attached to sutures with the concave side of thefastener facing a prosthetic device or tissue from which the free endsof the sutures extend.

FIG. 6 shows an alternative embodiment of a curved suture fastener 110that is similar to the fastener 100 but has greater curvature. Thesuture fastener 110 comprises an annular outer body 112, an inner tab114, and a “C” shaped slit 116. The increased curvature of the suturefastener 110 relative to the fastener 100 results in increased bias andincreased resistance to sutures sliding through the slit 116 toward theconcave direction. The embodiments 100 and 110 represent two examples ofdifferent curvatures, while other embodiments can have any other degreeof curvature desired. Similarly, the thickness of the curved suturefasteners may vary and is typically selected to provide a desiredstiffness for the fastener.

FIG. 7 shows an embodiment of a curved suture securement suture fastener120 that comprises an annular outer body 122 and two opposing tabs 124,126, similar to a flat version shown in FIGS. 3A-3C. The outer body 122has a generally circular shape and each of the tabs 124, 126 has agenerally half-circle shape. The tabs 124, 126 are separated from theouter body by two arcuate slots 128 and the tabs are separated from eachother by a straight slit 129 that connects the two arcuate slots 128.One or more sutures can be inserted into the slit 129 from the lowerconvex side, deflecting both tabs 124, 126 upwardly in the direction ofinsertion. With the sutures inserted, the biased tabs allow the suturesto move upwardly in the convex direction with little resistance butprevent the sutures from moving downwardly in the concave direction.

FIG. 8 shows another embodiment of a curved suture securement suturefastener 130 that comprises an annular outer body 132 and two opposingtabs 134, 136. The outer body 132 has a generally circular shape andeach of the tabs 134, 126 extends inwardly from opposite ends of theouter body. The tabs 134, 136 are separated from the outer body by twoarcuate slots 138 and the tabs are separated from each other by a slit139 that connects the two arcuate slots 138. The slit 139 preferably hasa straight middle portion for placement of sutures and angled orL-shaped end portions 131 at either end of the straight portion thathelp retain the sutures in the straight portion of the slit 139 andprevent the sutures from migrating into the arcuate slots 138. The twotabs 134, 136 are thus dissimilar, with the larger left tab 134extending around the right tab 136 on both sides at the L-shaped endportions 131 of the slit 139. One or more sutures can be inserted intothe slit 139 from the lower convex side, deflecting both tabs 134, 136upwardly in the direction of insertion. With the sutures inserted, thebiased tabs allow the sutures to move upwardly in the convex directionwith little resistance but prevent the sutures from moving downwardly inthe concave direction.

The suture fasteners disclosed herein may be formed from suitablebiocompatible material, including, for example, Nickel-Titanium or othershape-memory alloys, stainless steel, titanium, other metals, variousplastics, and other biologically-compatible materials. The illustratedsuture fasteners are mostly flat or curved disc-shaped bodies which arerelatively thin axially, and may be up to about 1-2 mm in height. Thediameter of the suture fasteners may be between 2-4 mm, but only needsto be sufficiently large to be incapable of penetrating asuture-permeable sewing edge of a cardiac implant, such as a sewing ringof a prosthetic heart valve or an annuloplasty ring. That is, the suturefasteners are wide enough to avoid being pulled through a sewing edge ofa cardiac implant when the sutures captured therein are placed undertension.

Braided sutures are used to attach prosthetic heart valves to annulusesas opposed to monofilament polypropylene sutures (e.g., Prolene) whichare used in other surgical environments. In the United States, suturediameter is represented on a scale descending from 10 to 1, and thendescending again from 1-0 to 12-0. A number 9 suture is 0.0012 in (0.03mm) in diameter, while the smallest, number 12-0, is smaller in diameterthan a human hair. Although suture size depends on surgeon preference,typically 1-0 or 2-0 braided sutures are used. In one embodiment, iflarger sutures are used the diameter of the suture fastener is up to 4mm, while if smaller sutures, such as 2-0, are used the diameter may beas small as 2 mm.

The knotless suture fasteners described herein include self-actuating orspring-loaded devices that clamp onto sutures. Passing one or moresutures through the suture fastener and then converting it from an opento a closed state causes features to collapse inward and clamp onto thesuture(s). The conversion desirably occurs upon removal of an impedimentto inward motion of clamping elements, though other spring-loadedconfigurations are possible. Such self-actuating suture fasteners arepreferred over plastically-deformable fasteners which must be crimpedover the sutures using forceps or other such compression tools. On theother hand, for added security a supplemental portion (not shown) of thesuture fasteners disclosed herein may be deformable so that a user maycrimp it onto the sutures—a hybrid fastener. For the purpose of definingterms, the term “self-actuating” suture fastener refers to aspring-biased type of device which does not require crimping, but which,on the other hand, does not exclude a crimpable portion. A“self-actuating” suture fastener is not entirely autonomous, in thatthere is a trigger prior to the deployment, such as removal of anelement or change in temperature, but the term excludes devices thatrequire mechanical crimping using a supplemental tool such as a hammerand anvil system.

Alternative self-actuating fasteners may be made of atemperature-activated memory material that biases the fastener to itsclosed configuration when exposed to a selected temperature range,though the control and timing of such devices add complexity. With thetemperature-activated memory material in its austenite state, thefastener tabs extend into the inner lumen to their greatest extent, sothat the fastener is in a “closed” configuration wherein the tabs blockmovement of any lengths of suture passing through the inner lumen. Theaustenite state can be set to occur when the suture fastener isgenerally unstressed and at human body temperature, so that whendeployed in the patient's body it will be remain biased toward itsclosed configuration.

Fastener Deployment Tools

FIG. 9 shows an exemplary fastener deployment tool 200 for installingthe suture fasteners disclosed in the present application having aproximal handle 202 and an elongated distal shaft 204 extendingtherefrom. The handle incorporates a trigger actuator 206, though otheractuators are contemplated. The total length of the deployment tool 200,and at least the length of the shaft 204, should be sufficient to extendfrom outside the surgical site to the aortic annulus, such as betweenabout 10-16 inches. The deployment tool 200 is intended to be reusedduring a surgical procedure, and is preferably made of materials thatenable sterilization for a subsequent procedure. For instance, the outershaft 204 is made from stainless steel tube, and may be available inmultiple lengths to facilitate a variety of surgical techniques duringheart valve repair or replacement, or for implant of other medicaldevices. An exemplary OD of the shaft 204 is about 3.2 mm (⅛ inch).

A subassembly 210 including a disposable fastener cartridge 212 andsuture snare 214 is configured to mate with a distal tip 216 of thedeployment tool shaft 204, and as such is shown slightly removedtherefrom in FIGS. 9 and 9A. The suture snare 214 may take a number offorms, and as illustrated includes a proximal pull tab 218 connected toa snare portion comprising a distal loop, hook or snare end 220 and aflexible wire or strip 222. In a preferred embodiment, the strip 222 isflexible stainless steel, and may also be configured as a wire or wireloop as seen below. As will be explained below, the snare end 220 andflexible strip 222 are fed through apertures and passages in thedisposable fastener cartridge 212 so that the snare end extends from adistal end of and generally along a central axis of the cartridge asshown.

An alternative embodiment of a suture snare 224 shown in FIG. 10includes a distal wire loop 226 connected to a proximal handle 228 inthe form of a bulb. The wire loop 226 is initially routed around aperipheral groove in a placement grip/key 229 for shipping, storage andhandling purposes and to prevent kinking of the loop. Either of thesuture snares 214, 224 may be used and provide a means for grasping oneor more sutures and pulling them through passageways in the fastenercartridge 212. The length of the flexible strip 222 or wire loop 226beyond the respective handle pull tab 218 or handle 228 is sufficient topass through the fastener cartridge 212 and extend beyond a sufficientdistance to enable grasping of sutures; the length being, for example,between about 2-8 inches.

FIG. 11A is a longitudinal sectional view of the deployment tool 200 ofFIG. 9 showing internal components, while FIGS. 11B-11D are detailedviews illustrating key moving parts therein. More particularly, thehandle 202 typically comprises a pair of molded halves defining a cavitytherein in which the trigger actuator 206 reciprocates. Pushing theactuator 206 inward, as indicated in FIG. 11B, rotates a lever arm 230about a pivot point 232. The upper end of the lever arm 230 acts via alinkage on a push rod 234 adapted to reciprocate within the hollow toolshaft 204. Consequently, the depression of the trigger actuator 206causes distal displacement of the push rod 234, while a spring return(not shown) of the trigger actuator retracts the push rod proximally.

With reference to FIGS. 11C and 11D, the distal end of the push rod 234fastens to a proximal end of a fastener ejector 236 having a main bodyportion which fits closely in the lumen of the tool shaft 204. Theejector 236 also has pair of bifurcated fingers 238 projecting from adistal end. It should be noted that a distal shoulder 240 located at thetransition between the main body of the ejector 206 and the distalfingers 238 has a relatively sharp corner angle, the purpose of whichwill be described below.

As seen in FIGS. 11D and 11E, the distal tip 216 of the tool shaft 204also features an outwardly projecting locking pin 242 and a side port244 generally opposite the pin for cooperating with the fastenercartridge and suture snare subassembly 210. The side port 244 opens tothe distal tip 216 via an L-shaped slot 246 having a circumferentialportion 248 a and an axial portion 248 b. As will be described belowwith reference to coupling of the fastener cartridge 212 with the toolshaft 204, the L-shaped slot 246 enables pull through of the suturesnare 214 upon registration of the shaft with the cartridge.

FIG. 12A is a perspective view of an exemplary disposable fastenercartridge 212, showing an exemplary suture fastener 250 held at a distalend thereof. The cartridge 212 has a generally tubular body 252 with anopen proximal mouth 254 with an axial slot 256 opening on one sidethereof. The slot 256 has a flared open end and intersects with acircumferential slot 258 approximately midway along the length of thecartridge body 252. The slot 258 terminates at a circular lockout 260.The combination of the axial slot 256, circumferential slot 258, andlockout 260 forms a bayonet-style latch that engages the distal tip 216of the tool shaft 204, as will be shown. It should be noted that theillustrated locking structure provided on the deployment tool shaft 204that engages the mating structure on the cartridge 212 is exemplaryonly, and other such configurations are contemplated. For example, thecartridge 212 may include threads that engage similar threads on thetool shaft 204, or the connection may be a spring-loaded bearing on theshaft 204 which snap fits into a groove on the cartridge 212.

With reference to the sectional views of FIGS. 12B and 12C, the body 252defines an inner lumen 262 that has a continuous diameter for most ofits length except for a generally annular inwardly directed rib 264 nearits distal end. The rib 264 extends around the perimeter of the lumen262 and has a pair of stops 266 projecting in a distal direction onopposite sides and spaced inward from the lumen 262. The stops 266 holdopen two biased tabs 268 on the suture fastener 250 for passage of thesuture snare and, ultimately, the sutures. The rib 264 having the stops266 is shown isolated in FIG. 12D, and generally comprises a ring-shapedelement with a square cross-section. The disposable fastener cartridge212 preferably comprises a thermoplastic molded over the rib 264, whichis preferably metal such as stainless steel, or more preferably acobalt-chromium alloy. The stainless steel rib 264 and its stops 266 aresufficiently hard to maintain the suture fastener 250 in an openposition without deformation, while the cartridge 212 as a whole is arelatively inexpensive item. In any one procedure, ten or more of thecartridges 212 and fasteners 250 may be used and discarded with minimalexpense. The deployment tool 200 is preferably reused, at least for theone procedure, and then may be sterilized for subsequent use.

The fastener 250 may be any of the fasteners described above, such asthose shown in FIGS. 3A-3D which have at least one and preferably twobiased tabs 34, 36 separated from a generally disc shaped body by slits.Although not shown, those of skill in the art will understand that aseparate assembly fixture (not shown) may be required to bias the tabs268 open and load the fastener 250 into the position held open by theprojections 266 as shown in FIGS. 12A-12C. The fasteners 250 aretypically formed a highly flexible stainless steel or superelastic suchas Nitinol.

The cartridge body 252 also includes an access port 270 typicallylocated opposite the lockout 260. As seen in FIG. 12C, the flexiblestrip 222 of the suture snare 214 passes into the access port 270,through the distal tip 216 of the tool shaft 204 (not shown), anddistally through a central opening in the annular rib 264 and betweenthe open suture fastener tabs 268. A full explanation of the cooperationbetween the various deployment components will be clear below.

FIG. 13A is a top plan view of the disposable fastener cartridge 212just prior to engagement with the distal tip 216 of the deployment toolshaft 204. To couple the two components, the cartridge 212 is displacedto the right so that the locking pin 242 on the shaft 204 enters theaxial slot 256 on the cartridge. The distal tip 216 fits closely withinthe lumen 262 of the cartridge 212, and eventually the pin 242 reachesthe end of the slot 256. The reader will notice that the axial portion248 b of the L-shaped slot 246 on the shaft 204 is aligned with theaccess port 270 on the cartridge 212, and thus travels over the segmentof the flexible strip 222 of the suture snare 214 that extendsdiagonally through the distal end of the cartridge.

FIG. 13B shows the fastener cartridge being rotated or twisted in theclockwise direction relative to the shaft 204 so that the pin 242travels along the circumferential slot 258 until it reaches the lockout260. In a preferred embodiment, the pin 242 is slightly wider than theslot 258, so that it “snaps” in to place within the lockout 260 as atactile and audible indicator of full engagement. It will be understoodthat the circumferential portion 248 a of the L-shaped slot 246 on theshaft 204 accommodates the flexible strip 222 as the cartridge and shaftare relatively rotated. That is, the flexible strip 222 as well as theaccess port 270 on the cartridge 212 eventually end up in registry withthe side port 244 on the shaft 204 (see FIGS. 11C and 11E).

FIGS. 13A and 13B show placement of the flexible strip 222 of the suturesnare 214 through the engaged components. More particularly, the strip222 extends radially inward through the access port 270 in the cartridgebody 252, through the port 244 (see FIG. 11C) in the shaft 204, and thenaxially through the open fastener 250. This is also illustrated in FIG.14A. Because of the L-shaped slots formed in both the shaft 204 andcartridge 212, the suture snare 214 is ready to use once the twocomponents are joined together. That is, the subassembly of thecartridge 212 and suture snare 214 are pre-assemble and packaged incombination with a number of other subassemblies (i.e., packs of 6) foruse with one of the delivery tools 200. By simply coupling eachcartridge subassembly to the tool shaft 204, as explained above, thedelivery system is ready to install the suture fastener 250.

FIGS. 14A-14D are longitudinal sectional views through the disposablefastener cartridge 212 engaged with the end of the deployment tool 200,and illustrating steps in deploying the suture fastener 250. Theassembly described above is first shown in FIG. 14A, which is theconfiguration just prior to introduction of the tool 200 to theimplantation site for deployment of the fastener 250. The deploymentsequence can also be understood with reference to FIGS. 15A-15B, whichwill be described in parallel.

FIG. 15A illustrates an ascending aorta opened up during a step inattachment of a surgical prosthetic heart valve HV to the aortic annulususing knotless suture fasteners 250. The heart valve HV is of a typehaving flexible leaflets L supported by commissure posts that extend inan outflow direction of the valve. The commissure posts form a part ofan internal support frame (not shown) typically covered by fabric.Secured around an inflow end of the support frame, a peripheral sewingring SR provides an anchoring zone for a plurality of anchoring suturesS that are pre-installed at the aortic annulus.

The surgeon pre-attaches the anchoring sutures S at evenly spacedlocations around the aortic annulus. The anchoring sutures S aretypically looped twice through the annulus from the outflow or ascendingaorta side to the inflow or ventricular side. Of course, other suturingmethods or pledgets may be used depending on surgeon preference. Onceeach anchoring suture S is secured to the annulus, it extends proximallyin pairs of free lengths out of the operating site. The heart valve HVis typically mounted on a valve holder and delivery handle (not shown),and the surgeon threads the pairs of anchoring sutures S through evenlyspaced locations around the sewing ring SR corresponding to theirlocations around the annulus. The surgeon then advances the valve HVinto position within the aortic annulus along the array of anchoringsutures S. Some of the anchoring sutures S are not shown around thefront of the heart valve HV in FIG. 15A for clarity.

Subsequently, the surgeon installs a suture fastener 250 on each pair ofanchoring sutures S on the proximal or outflow side of the sewing ringSR. This is accomplished using the fastener deployment tool 200 inconjunction with the suture snare 214. First, the surgeon captures twofree lengths of a pair of anchoring sutures S with the snare end 220 ofthe snare 214 using forceps, for example. Subsequently, the surgeonpulls the suture snare 214 proximally through and out of engagement withthe deployment tool 200, as indicated by the arrows in FIG. 14B. Thispulls the anchoring sutures S through the suture fastener 250, throughthe internal channels of the cartridge 212 and deployment tool 200, andout of the side port 244.

The surgeon then maintains tension on the anchoring sutures S throughthe side port 244, and advances the shaft 204 of the deployment tool 200distally until it contacts the valve sewing ring SR. The suture fastener250 is then deployed using the trigger actuator 206 (FIG. 9) on thedeployment tool 200, as will be explained with reference to FIGS. 14Cand 40D, so that it clamps down on the anchoring sutures S. Thedeployment tool 200 can then be retracted and the anchoring sutures Ssevered just above the suture fastener 250 using scissors or a cutterintegrated with the deployment tool. FIG. 15B shows a majority of thefasteners 250 already installed around the sewing ring SR to secure theheart valve HV to the aortic annulus.

After pulling the sutures S in a proximal direction through the fastener250, cartridge 212 and deployment tool 200, the surgeon triggers theactuator 206 which displaces the push rod 234 distally. As seen in FIG.14C, the bifurcated fingers 238 at the distal end of the ejector 236eventually contact the inwardly bent tabs 268 and force the suturefastener 250 out of the cartridge 212. The fingers 238 have a reduceddiameter relative to the body of the ejector 236 so as to fit throughthe central opening of the annular rib 264. Furthermore, the bifurcatednature of the fingers 238 provides a passageway for the sutures S andprevents the fingers from binding the sutures, such as against thefastener 250. As soon as the fastener 250 is pushed off of the stops266, the biased tabs 268 spring back toward their natural, relaxed shape(which, in the illustrated embodiment is in the plane of the rest of thefastener), clamping down on the sutures S. Assuming the surgeon haspositioned the distal end of the cartridge 212 against the heart valvesewing ring SR, the fastener 250 provides an anchor to hold the sewingring against the annulus at that point.

Now with reference to FIG. 14D, further deployment of the actuator 206and distal displacement of the push rod 234 severs the sutures S. Inparticular, the sharp corner 240 on the ejector 236 travels past thedistal edge of the side port 244 in the deployment tool shaft 204. Theside port 244 may also have a sharp corner, and the interaction betweenthese two sharp corners creates a shearing action sufficient to severthe sutures S. Of course, this step may be omitted in favor of simplycutting sutures S close to the fastener 250 after removing the tool 200.

The heart valve HV is representative of numerous types of heart valves,including those with flexible leaflets as shown and also mechanicalvalves with rigid metallic leaflets, in addition to other surgicalimplants as mentioned above. Further, the flexible leaflet heart valveHV is shown with the suture fasteners 250 deployed from an outflow sideof the valve, which typically indicates that the valve is for implant atthe aortic annulus where the outflow is also the proximal side relativeto conventional heart valve delivery. However, it should be understoodthat the suture fasteners 250 could be reversed within the heart valveHV so that they are deployed from the inflow side, such as in a mitralvalve replacement procedure.

FIGS. 16A-16D illustrate an exemplary disposable fastener cartridge 212with an alternative suture snare 300 during loading of the cartridge toa distal tip of the deployment tool and preparing the suture snare foruse. Parts that are similar to those described above will be given thesame number. In particular, the deployment tool has an elongated toolshaft 204 that terminates in a distal tip 216 to which the cartridge 212attaches.

In this embodiment, a marker line 302 is provided on the same side ofthe tool shaft 204 as the locking pin 242 and extends a short distancefrom the distal tip 216 in a proximal direction. This marker line 302facilitates alignment of the axial slot 256 on the cartridge 212 withthe locking pin 242. FIG. 16A shows relative displacement of thesubassembly of the cartridge 212 and suture snare 300 toward the toolshaft 204. Eventually, as described above with respect to FIG. 13A, thelocking pin 242 reaches the end of the axial slot 256.

FIG. 16B shows 90° clockwise rotation of a placement grip/key 304 of thesuture snare 300 relative to the tool shaft 204. This also rotates thefastener cartridge 212 relative to the shaft 204. As was explained abovewith respect to FIG. 13B, the locking pin 242 travels along thecircumferential slot 258 on the cartridge 212 until it reaches and snapsinto the lockout 260 (best seen in FIG. 12A). An additional indicator ofcomplete engagement is the alignment of a second marker line 305 on thecartridge 212 with the marker line 302 on the shaft 204. At the sametime, the circumferential portion 248 a of the L-shaped slot 246 on theshaft 204 (see FIG. 11E) accommodates two strands of a flexible snarewire 306 as the cartridge and shaft are relatively rotated.

The snare 300 comprises the key 304, wire 306, and a proximal handle 308in the form of a bulb. The flexible wire 306 extends from the proximalhandle 308 and loops around the placement grip/key 304, preferably beingheld within an outer groove 309 therein. The loop formed by the wire 306is routed around the groove 309 in the placement grip/key 304 forshipping, storage and handling purposes and to prevent twisting ortangling of the loop.

Subsequently, the user pulls the placement grip/key 304 axially awayfrom the fastener cartridge 212 to create some separation therebetween,as seen in FIG. 16C. The two strands of the flexible wire 306 are thusexposed. At this point, the placement grip/key 304 can be removed fromwithin the loop of the flexible wire 306 by pushing down on its proximalend, as seen in FIG. 16D. The suture fastener delivery system is nowready to use.

FIGS. 17A-17F show sequential steps in operation of the deployment tool200 and fastener cartridge 212 during installation of a suture fastener250 on the proximal side of an annuloplasty ring, such as theannuloplasty ring 2 shown in FIG. 1. FIG. 17A shows a technician passingone or more strands of sutures 310 through the loop of the flexible wire306. In the illustrated embodiment, there are two strands of sutures 310which represent a pre-installed suture that has been passed through anative heart valve annulus, and then through a peripheral sewing edge ofthe annuloplasty ring 2. A minimum of 5 cm of the sutures 310 are passedthrough the snare loop 306 to ensure that they remain captured whilepulled through the cartridge 212.

FIG. 17B illustrates the user pulling on the proximal handle 308 whichin turn pulls the flexible wire loop 306 through the fastener cartridge212, and also pulls the two strands of sutures 310 with it. The userthen grasps the sutures 310 with one of his or her hands, as seen inFIG. 17C, to place the sutures in tension through the ring 2 to theannulus.

As seen in FIG. 17D, the user advances the distal tip of the shaft 204having the cartridge 212 thereon down the sutures 310 to the targetlocation on the annuloplasty ring 2. Only a portion of the annuloplastyring 2 is shown indicating that several suture fasteners 250 are alreadyinstalled.

Finally, as seen in FIG. 17E, the user actuates the delivery tool suchas by pulling the trigger actuator 206 as explained above, to deploy thesuture fastener 250 and simultaneously cut the sutures 310. FIG. 17F isan enlargement of the installed suture fastener 250 showing shortlengths of the sutures 310 remaining At this stage, the fastenercartridge 212 will be removed from the shaft 204 to make way for anothercartridge that has a suture fastener loaded therein.

FIGS. 18A-18C show the steps necessary for disengagement of a usedfastener cartridge 212 from the distal tip of the deployment tool shaft204. Disengagement is opposite from engagement, and involves rotatingthe cartridge 212 counterclockwise 90° and then pulling it axially freefrom the shaft 204. The deployment tool 200 is then ready for couplingwith another fastener cartridge. Engagement of a disposable fastenercartridge 212 and suture snare 300 with the tool shaft 204, applicationof the suture fastener 250 to the target location, and removal of thespent cartridge 212 from the tool shaft 204 can be done in a very shortamount of time. Cycle times of less than a minute are possible. This issignificantly shorter than the time that it would take to tie off eachof the sutures with a knot, especially in keyhole surgeries where spacearound the implant is limited.

FIG. 19 is a perspective cutaway view of the subassembly of thedisposable fastener cartridge 212 and exemplary suture snare 300 ofFIGS. 16A-16D. The fastener cartridge 212 has been described above, andwill not be explained here other than to note that FIG. 20 is anexploded perspective view of the cartridge and a suture fastener 250.

As explained above, the suture snare 300 comprises the placementgrip/key 304 connected via the flexible wire 306 to the proximal handle308. The placement grip/key 304 and proximal handle 308 are desirablymade of a relatively soft polymer such as an elastomer. A proximal endof the key 304 includes an enlarged annular sleeve 320 having an innerdiameter that is sized approximately the same as the outer diameter ofthe fastener cartridge 212. The annular sleeve 320 can thus be pushedover the distal tip of the cartridge 212 and it will be held thereon bya close interference fit. The flexible wire 306 passes inward throughthe aligned ports 270, 244, as explained above, out through the suturefastener 250 at the distal end of the cartridge 212, backward betweenthe sleeve 320 and the cartridge, and then into the peripheral groove309 around the key. In a preferred embodiment, the flexible wire 306 isformed of an annealed stainless steel having a diameter of approximately0.007 inches, and has sufficient flexibility to withstand kinking whenrouted in this manner.

While the disclosed technology has been described in its preferredembodiments, it is to be understood that the words which have been usedare words of description and not of limitation. Therefore, changes maybe made within the appended claims without departing from the true scopeof the invention(s).

What is claimed is:
 1. A system for securing a suture, comprising: adeployment tool having a proximal portion and a distal shaft; and asubassembly configured to attach to the distal shaft of the deploymenttool, the subassembly comprising: a cartridge having a lumen, wherein aproximal portion of the cartridge is configured to engage with thedistal shaft of the deployment tool; a suture fastener coupled to thecartridge, the suture fastener having a clamping structure that is heldby the cartridge in a resiliently deformed open position wherein asuture can pass through the clamping structure, and the clampingstructure being biased toward a closed position in which the clampingstructure resiliently clamps onto a suture passed therethrough; and asuture snare having a snare portion extending through the suturefastener, the suture snare being adapted to receive a suture and pullthe suture proximally through the suture fastener; wherein thedeployment tool is configured to cause the suture fastener to deployfrom the cartridge such that the suture fastener resiliently changesfrom the open position to the closed position to clamp onto a sutureextending through the suture fastener.
 2. The system of claim 1, whereinthe deployment tool comprises a proximal handle with a trigger, and anejector that extends through the distal shaft, and the ejector islongitudinally movable within the distal shaft upon actuation of thetrigger, such that the ejector is configured to push the suture fastenerto deploy the suture fastener from the cartridge.
 3. The system of claim2, wherein the ejector further includes a sharp edge, such that movementof the ejector severs a suture extending through the suture fastener andout of the cartridge.
 4. The system of claim 1, wherein the suturefastener comprises a disk-shaped main body, and the clamping structurecomprises at least one tab extending radially inwardly from the mainbody and being spring-biased toward the closed position where the atleast one tab is aligned with the main body; and wherein at least onestop on the cartridge maintains the suture fastener in its open positionby causing the at least one tab to be flexed out of alignment with themain body.
 5. The system of claim 1, wherein the suture snare comprisesthe snare portion, a handle connected to the snare portion, and a griphaving a peripheral groove for receiving and holding open a flexibleloop of the snare portion, and wherein the grip is detachably coupled toa distal end of the cartridge.
 6. The system of claim 1, wherein thecartridge is tubular and its proximal end includes a generally “L”shaped slot terminating in a circular lockout that receives a lockingpin extending radially outwardly from the deployment tool distal shaft,the cartridge engaging the distal shaft of the deployment tool byaxially advancing and then rotating thereover to position the lockingpin in the circular lockout.
 7. The system of claim 6, wherein thegenerally “L” shaped slot has an axially-extending portion and acircumferentially extending portion, and wherein the axially-extendingportion aligns with a first port located on the cartridge, and thecircumferential portion terminates in a second port located on the tooldistal shaft, the first and second ports being aligned when thecartridge and tool distal shaft are fully engaged.
 8. An assemblyconfigured to be attached to a suture fastener deployment tool, theassembly comprising: a cartridge having a proximal portion that isconfigured to engage with the distal portion of the deployment tool; asuture fastener coupled to the cartridge, the suture fastener having aclamping structure that is held by the cartridge in a resilientlydeformed open position wherein a suture can pass through the clampingstructure, the clamping structure being biased toward a closed positionin which the clamping structure resiliently clamps onto a suture passedtherethrough; and a suture snare having a snare portion extendingthrough the suture fastener in the open position, the snare portionbeing adapted to receive a suture and pull the suture proximally throughthe suture fastener.
 9. The assembly of claim 8, wherein the suturefastener comprises a disk-shaped main body, and the clamping structurecomprises at least one tab extending radially inwardly from the mainbody and being resiliently biased toward the closed position where theat least one tab is aligned with the main body; and wherein at least onestop on the cartridge maintains the suture fastener in its open positionby causing the at least one tab to be flexed out of alignment with themain body.
 10. The assembly of claim 8, wherein the suture snarecomprises the snare portion, a handle connected to the snare portion,and a grip having a peripheral groove for receiving and holding open aflexible loop of the snare portion, and wherein the grip is detachablycoupled to a distal end of the cartridge.
 11. The assembly of claim 8,wherein the cartridge includes a metallic insert that forms at least onestop that maintains the suture fastener in the open position, the insertbeing positioned in a generally tubular polymeric body of the cartridgehaving an inner passageway, the stop being within the inner passageway.12. The assembly of claim 8, wherein the cartridge is tubular and asidewall of the cartridge includes a generally “L” shaped slotterminating in a circular lockout that is configured to receive alocking pin from a distal shaft of a suture fastener deployment tool.13. The assembly of claim 12, wherein the generally “L” shaped slot hasan axially-extending portion that opens at a proximal end of thesidewall and a circumferentially extending portion that includes thecircular lockout.
 14. An assembly comprising: a cartridge having aproximal portion that is configured to be coupled to a distal portion ofa suture fastener deployment tool; a suture fastener coupled to a distalportion of the cartridge, the suture fastener having a clampingstructure that is held by the cartridge in a resiliently deformed openposition wherein a suture can pass through the clamping structure, theclamping structure being biased toward a closed position in which theclamping structure resiliently clamps onto a suture passed therethrough;and an insert that comprises at least one stop that maintains the suturefastener in the open position, the insert being positioned within thecartridge adjacent the suture fastener such that the at least on stop isengaged with the clamping structure of the suture fastener.
 15. Theassembly of claim 14, wherein the cartridge comprises a polymericmaterial and the insert comprises a metallic material.
 16. The assemblyof claim 14, wherein the cartridge is tubular and a sidewall of thecartridge includes a generally “L” shaped slot terminating in a circularlockout that is configured to receive a locking pin from a distal shaftof a suture fastener deployment tool.
 17. The assembly of claim 16,wherein the generally “L” shaped slot has an axially-extending portionthat opens at a proximal end of the sidewall and a circumferentiallyextending portion that includes the circular lockout.
 18. The assemblyof claim 14, wherein the suture fastener comprises a disk-shaped mainbody, and the clamping structure comprises at least one tab extendingradially inwardly from the main body and being resiliently biased towardthe closed position where the at least one tab is aligned with the mainbody; and wherein the at least one stop maintains the suture fastener inits open position by causing the at least one tab to be flexed out ofalignment with the main body.
 19. The assembly of claim 14, wherein thecartridge comprises a radial opening positioned proximal to the suturefastener, the radial opening configured to allow a suture snare toextend radial into the cartridge, axially through the suture fastener,and out of the distal portion of the cartridge.
 20. The assembly ofclaim 14, wherein the insert comprises an annular body positionedproximal to the suture fastener, and the insert comprises two spacedapart stops that extend distally from the annular body through theclamping structure to maintain the suture fastener in the open position.